REINVENTING THERAPEUTICS. REVITALIZING HEALTHCARE.

WHO WE ARE

ABOUT

Roivant’s mission is to reduce the time and cost of developing new medicines for patients and to share those savings with the healthcare system. We are a unique biopharmaceutical company with world-class drug development experts working across multiple clinical and functional areas.

OUR WORK

PIPELINE

Roivant Sciences builds its pipeline through strategic alliances, collaborations and partnerships with academic institutions and other pharmaceutical companies. Our company has several ongoing late-stage clinical development programs spanning multiple indications and technologies.

MILD-TO-MODERATE ALZHEIMER’S DISEASE

Alzheimer’s disease is the most common form of dementia and the sixth leading cause of death in the United States. A chronic, progressive neurodegenerative disorder, Alzheimer’s usually develops slowly and can get worse over time. According to the Alzheimer’s Association, Alzheimer’s disease affects approximately 5.3 million people in the United States today and the number of patients afflicted with the disease is growing every year. By 2050, it is projected that the population living with Alzheimer’s disease over the age of 65 will approximate 14 million people.

An estimated 80% of Alzheimer’s disease patients age 65 and older are classified as mild-to-moderate, which is the patient population we are focused on treating with intepirdine (RVT-101).

In 2015, total healthcare costs for Alzheimer’s and other dementias were $226 billion in the US alone. No new treatment options for patients have been approved by the FDA for the treatment of Alzheimer’s disease since 2003. Axovant is currently developing intepirdine in a Phase 3 international, multicenter, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and efficacy of intepirdine in mild-to-moderate Alzheimer’s disease patients called the MINDSET study.

DEMENTIA WITH LEWY BODIES (DLB)

Lewy body dementia, or LBD, is a chronic, progressive neurodegenerative disorder and represents the second most common form of dementia. LBD is characterized by a build-up of abnormal proteins known as Lewy bodies in areas of the brain that control cognition, movement, alertness, and behavior.

Lewy body dementia includes two similar conditions – dementia with Lewy bodies, or DLB, and Parkinson’s disease dementia, or PDD. The primary difference between both conditions generally depends on the timing of the onset of cognitive decline relative to the onset of movement-related symptoms.

In dementia with Lewy bodies, cognitive decline generally occurs within one year of the onset of movement disorder symptoms. In Parkinson’s disease dementia, movement disorder symptoms precede cognitive decline by more than a year.

Along with suffering from impaired cognition and behavioral disturbances, LBD patients often suffer from: visual hallucinations; fluctuations in cognition, attention and alertness; sensitivity to neuroleptic (antipsychotic) medications; REM behavior disorder, or RBD, in which people physically act out their dreams; and Parkinsonism (movement disorder, with symptoms including muscle rigidity and tremors).

The Lewy Body Dementia Association estimates that there are 1.4 million patients with Lewy body dementia in the United States.

Our subsidiary, Axovant, is currently developing two drug candidates to treat certain aspects of Lewy body dementia – intepirdine (RVT-101) and nelotanserin. Currently, there are no drugs approved by the FDA for the treatment of DLB. Intepirdine has the potential to be the first drug approved by the FDA for the treatment of DLB.

VISUAL HALLUCINATIONS IN LEWY BODY DEMENTIA

The safety, efficacy, and tolerability of nelotanserin at doses of 40 mg and 80 mg will be evaluated over a 4-week treatment period in approximately 20 subjects with LBD. This is a crossover study so every subject will receive placebo for 4 weeks and nelotanserin for 4 weeks, but neither patients or their doctor will know which treatment they are taking. The primary outcome measure will be safety and tolerability. The frequency and severity of visual hallucinations over a 4-week treatment period will be a secondary outcome measure. Patients who complete the study will be eligible to receive nelotanserin in an extension study.

The efficacy, safety, and tolerability of 80 mg of nelotanserin will be evaluated over a 4-week period in approximately 60 patients with DLB. The primary efficacy evaluation will be a change in the frequency of REM sleep behaviors by the end of 4 weeks. Patients who complete the study will be eligible to receive nelotanserin in an extension study.

UTERINE FIBROIDS

Uterine fibroids are non-cancerous tumors that develop from the muscle and connective tissue of the uterus. Approximately 25% of women of reproductive age have uterine fibroids, and 1 in 4 experience symptoms requiring treatment. Although uterine fibroids are benign tumors, they may cause debilitating symptoms including heavy and prolonged menstrual bleeding, anemia, and pelvic pain. Current treatments include hormonal contraceptives, GnRH agonists, and surgical interventions including myomectomy and hysterectomy.

Myovant is currently developing relugolix, an oral, once-daily, gonadotropin-releasing hormone (GnRH) receptor antagonist. By inhibiting GnRH receptors in the anterior pituitary gland, relugolix rapidly reduces the circulating gonadotropin luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to the suppression of estrogen in women and testosterone in men. Suppression of these hormones improves the symptoms of uterine fibroids and endometriosis in women and decreases prostate-specific antigen (PSA) levels in men with advanced prostate cancer.

ENDOMETRIOSIS

Endometriosis is a gynecological medical condition in which cells that normally line the uterus grow outside of the uterine cavity. An estimated 7.5 million women in the United States have endometriosis, and 3 in 4 experience symptoms requiring treatment. During the menstrual cycle, endometriosis lesions grow, differentiate, and shed into the abdomen, causing symptoms including non-menstrual pelvic pain and pain during menstruation (dysmenorrhea). Current treatments include hormonal contraceptives, danazol, GnRH agonists, and various surgical interventions for severe cases.

Myovant is currently developing relugolix, an oral, once-daily, gonadotropin-releasing hormone (GnRH) receptor antagonist. By inhibiting GnRH receptors in the anterior pituitary gland, relugolix rapidly reduces the circulating gonadotropin luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to the suppression of estrogen in women and testosterone in men. Suppression of these hormones improves the symptoms of uterine fibroids and endometriosis in women and decreases prostate-specific antigen (PSA) levels in men with advanced prostate cancer.

FEMALE INFERTILITY

Approximately 25% of infertile women have problems related to ovulation, including the inability to produce fully matured eggs or release an egg from the ovary (i.e., “ovulate”). In the course of treating infertility related to anovulation, fertility specialists use a group of medications to temporarily correct ovulatory problems and increase a woman’s chance for pregnancy. These and related procedures are broadly termed Assisted Reproductive Technology, or ART. Approximately 1.5 million cycles of ART were performed globally in 2012.

Myovant is currently developing RVT-602, an analog of kisspeptin, a naturally-occurring peptide in humans that plays a key role in egg maturation and ovulation by increasing the release of LH and FSH through the stimulation of GnRH secretion.

Recent evidence from trials performed in women undergoing assisted reproduction revealed that the native kisspeptin peptide has the potential to act as an alternative to human chorionic gonadotropin (hCG) or GnRH agonists in triggering egg maturation, an essential step in all assisted reproduction cycles. Myovant believes that RVT-602 may induce the release of LH and FSH in a manner that more closely mimics natural physiology, potentially avoiding side effects associated with hCG or GnRH agonist administration, including ovarian hyperstimulation syndrome (OHSS).

PROSTATE CANCER

Prostate cancer is a malignant transformation of tissue within the male prostate gland. Often characterized by slow growth, prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the United States. Approximately 2.9 million men in the United States are currently living with prostate cancer, and 180,000 men are newly diagnosed each year. Symptoms of prostate cancer include increased urinary frequency, dysuria, hematuria, and nocturnal urination. Current treatments include combinations of surgery, radiation or proton beam therapy, androgen deprivation therapy, and chemotherapy.

Myovant is currently developing relugolix, an oral, once-daily, gonadotropin-releasing hormone (GnRH) receptor antagonist. By inhibiting GnRH receptors in the anterior pituitary gland, relugolix rapidly reduces the circulating gonadotropin luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to the suppression of estrogen in women and testosterone in men. Suppression of these hormones improves the symptoms of uterine fibroids and endometriosis in women and decreases prostate-specific antigen (PSA) levels in men with advanced prostate cancer.

FARBER DISEASE

Farber disease is an ultra-rare lysosomal storage disease caused by a mutation in both alleles of the ASAH1 gene, resulting in the deficiency of the lysosomal enzyme acid ceramidase. This leads to the accumulation of the pro-inflammatory sphingolipid ceramide, and a macrophage driven inflammatory process causing the development of typical clinical symptoms. Like many other lysosomal storage diseases, Farber disease has a broad phenotypic spectrum, and is likely underdiagnosed.

Farber patients typically present with the cardinal symptoms of joint contractures or arthritis, subcutaneous nodules, and weak or hoarse voice.

It may take years for all three cardinal symptoms to appear together, and they may vary greatly in severity. Patients may also present with systemic inflammation (fever), severe pain, peripheral osteolysis, failure to thrive, and developmental delay.

Recombinant human acid ceramidase (rhAC) is an enzyme replacement therapy (ERT) under development for the treatment of Farber disease. Initially developed by Dr. Edward Schuchman at the Icahn School of Medicine at Mount Sinai, rhAC showed positive results in various preclinical studies. rhAC was granted orphan drug designation by the U.S. Food and Drug Administration. Enzyvant is currently conducting the pre-clinical studies for rhAC to enable a clinical trial in patients with Farber disease.

MILD-TO-MODERATE ATOPIC DERMATITIS

A research study is now enrolling adults and adolescents with mild to moderate atopic dermatitis (also called eczema). If you or your adolescent child has eczema, he or she may be eligible for a research study involving an investigational topical non-steroidal drug.

WHO WE WORK WITH

PARTNERS

Roivant Sciences has strategic alliances with partners who share our patient-centric commitment to develop promising drug candidates into approved medicines. Our company delivers R&D solutions to our biopharmaceutical industry partners, enabling them to unlock value from their pipelines and scale their businesses.

Roivant seeks late-stage drug candidates with the potential for accelerated regulatory approval timelines, where our significant capital base and world-class development expertise can maximize the opportunity for these drugs to positively impact the lives of patients. Our company will selectively evaluate regional or global product opportunities across all therapeutic areas, mechanisms of action, routes of administration, and levels of innovativeness.

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By submitting this form, you are consenting to receive an email response with relevant information from Roivant Sciences. You may also receive relevant information from us in the future. You will have the ability to opt out of receiving emails or mailings at any time. View our Privacy Policy

By submitting this form, you are consenting to receive an email response with relevant information from Roivant Sciences. You may also receive relevant information from us in the future. You will have the ability to opt out of receiving emails or mailings at any time. View our Privacy Policy